(394 days)
The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures.
The HipSextant Instrument is a manual mechanical acetabular positioning device. The devices is used in conjunction with CT mapping of the individual patients pelvis. The instrument has three legs which land on the pelvis. The legs form three points which define the sextant plane. The sextant has two protractors that are adjusted to orientate a direction pin in the direction of the desired orientation of the acetabular component. During surgery a small pin is placed into the ischium and a cannulated leg and the sextant are seated onto the ischium. The second leg is seated onto the lateral side of the anterior spine by placing an arthroscopic style trocar through a cannula. Finally, a third leg is also seated using a trocar. With the sextant firmly docked onto the pelvis, the cup impactor is then aligned with the sextant direction pin. The device is used with an Excel spreadsheet which is used to assist the surgeon in performing calculations regarding alignment.
The provided text describes a 510(k) submission for the Hip Sextant Instrument System, a manual surgical instrument used to align acetabular components during hip arthroplasty procedures. However, the document does not contain the specific information required to complete all parts of your request regarding acceptance criteria and a study proving those criteria are met.
Here's what can be extracted and what information is missing:
Missing Key Information:
- Specific Acceptance Criteria: The document mentions "successfully passed clinical and nonclinical testing" but does not define any specific quantitative acceptance criteria for device performance (e.g., accuracy of alignment in degrees, precision, error margins).
- Detailed Study Design and Results: While "clinical experience" and "validation of software" are listed as tests, there are no details about study design, participants, comparative effectiveness, or specific numeric results that would allow for a table of acceptance criteria vs. reported performance.
- Sample sizes (test set and training set): Not mentioned.
- Data provenance: Not mentioned.
- Number of experts/qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC study information: Not mentioned.
- Effect size of AI assistance: Not applicable as this is a mechanical device, not an AI system.
- Standalone performance: Not applicable in the context of AI. The device is a "manual mechanical acetabular positioning device" implying it's used by a surgeon.
- Type of ground truth: Not mentioned.
- How ground truth for training set was established: Not mentioned.
Based on the provided text, here is what can be inferred or directly stated:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred/General) | Reported Device Performance (General) |
|---|---|
| Biocompatibility | "The subject device is composed of medical grade biocompatible materials." |
| Sterilization Efficacy | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Sterilization Validation" |
| Cleaning Efficacy | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Cleaning Validation (including protein residual)" |
| Durability/Repeated Use | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Repeated autoclave studies to evaluate performance and wear" |
| Software Functionality (for calculations) | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Validation of software used in conjunction with the device to perform calculations." (The device is used with an Excel spreadsheet for calculations). |
| Clinical Use (Safety & Effectiveness) | "The subject device has been subjected and successfully passed clinical and nonclinical testing including... Clinical experience." The submission concludes: "We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate devices." (No specific quantitative performance metrics like alignment accuracy are provided.) |
| Substantial Equivalence to Predicate Devices | "Surgical Planning Associates, Inc. believes that the subject device is substantially equivalent to the cited predicate devices. ...the conclusion of substantial equivalency is based on the identical indications for use, design concept, level of surgical invasiveness, and that all cited instruments are metal and reusable. Equivalence is further substantiated by clinical and nonclinical data." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the validations or clinical experience.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document mentions "clinical experience" but does not detail how ground truth was established or by whom.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable/not performed as this is a mechanical surgical instrument, not an AI or imaging diagnostic device.
- Effect Size of AI assistance: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a manual mechanical device, not an algorithm/AI. The device is explicitly stated to be a "manual mechanical acetabular positioning device" used "in conjunction with CT mapping" but actively manipulated by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. The general statement "clinical experience" does not elaborate on the type of ground truth used to assess performance.
8. The sample size for the training set
- Not applicable/not specified. This is a mechanical device, not an AI system that requires a "training set" in the machine learning sense. The "validation of software" implies software testing, but a "training set" for the device itself is not relevant here.
9. How the ground truth for the training set was established
- Not applicable/not specified, as there is no "training set" in the context of this mechanical device.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).